Phase II Study of Resistant Potato Starch Plus Deferasirox to Improve Outcomes in Patients Undergoing Allogeneic Stem Cell Transplantation

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan Rogel Cancer Center
Study ID
NCT06784336
Phase
PHASE2
Status
Recruiting
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Conditions

  • Allogeneic Stem Cell Transplant

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Iron chelation — DRUG
    Patients will receive Iron chelation with deferasirox (Jadenu 7 mg/kg/day preferred versus Exjade 10 mg/kg/day) beginning on day -14 and continuing through day +100
  • Potato Resistant Starch — DRUG
    Patients will receive PRS beginning on day -6 and continuing through day +100. Patients will take 20g packet twice daily

Study Details

The study will evaluate the safety and early efficacy of administering the combination of a commercially available potato-based resistant starch along with iron chelation therapy to subjects undergoing alloHCT.

Key Dates

Start date
Oct 15, 2025
Status verified
Nov 2025
Primary completion
Oct 31, 2028
Completion
Oct 31, 2029

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Study Treatment
    All subjects will be enrolled into one arm and will be treated with RPS and Iron Chelation

Primary Outcome Measure

GVHD-free and relapse-free survival [ Time Frame: up to 1 year post- transplantation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Michigan Rogel Cancer CenterAnn ArborMichigan48187
Mary Riwes, D.O.
[email protected]
734-936-8785
Mary Riwes (PRINCIPAL_INVESTIGATOR)

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By research site
University of Michigan Rogel Cancer Center· Ann Arbor, MI

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